The present invention relates generally to an improved length of self-retaining suture and, more particularly, relates to converging sections of self-retaining suture as well as the method and device for using the same.
Self-retaining sutures have been used in the past in many different surgical applications. Self-retaining sutures have been shown to perform particularly well in binding together various body parts such as skin, muscle tissue, organs, blood vessels, tendons, organs and the like. Self-retaining sutures are advantageous to the surgical team because they provide an effective ligature of tissue without the requirement of an anchoring suture knot which can be difficult to tie and which can cause damage to tissue during the wound healing process. Self-retaining sutures also simplify many tissue repair applications by more evenly distributing repair retention forces along the length of the suture. The optimization of self-retaining sutures is disclosed in detail in U.S. Patent Publication US 2004/0060409A and is incorporated herein in its entirety.
Typically, self-retaining sutures have been used to bind mammalian body parts together by passing a first length of self-retaining suture through a first section of tissue to be bound in a direction in which the retainers may pass relatively freely in one direction through the tissue, but will resist movement if the suture is moved in the direction opposed to the insertion direction. Then a second length of suture is passed through a second section of tissue in a second direction. Finally, the surgeon joins the two lengths together by tying them or otherwise binding them together.
One alternative method for use of a self-retaining suture is to use a single length of rigid self-retaining suture having a first end, a second end and the retainers disposed on the length of the suture in a bidirectional fashion. A portion of the length of the suture has retainers facing a first end and a portion of the length of the suture has retainers facing the second end. The suture binds tissue together by inserting the first end in a first section of tissue and inserting the second end in a second section of tissue. The diverging retainers resisted movement of the sections away from the wound and help bind them together. This retainer design and methodology is disclosed more fully in U.S. Pat. No. 6,241,747B1 and is incorporated herein in its entirety.
Further, there are devices for use in inserting self-retaining sutures into the body of a mammal. These include tubular instruments having a hollow portion for holding a length of self-retaining suture. The end of the instrument includes a holding point for a pointed first end of the suture length and the front of the instrument includes a handle. In use, the end of the instrument is inserted into the body of a mammal at the point. The instrument, guided by the user holding it at the handle, is inserted along a pathway through an incision or wound for closure and up through the tissue, or the like, where the pointed end can clear the subject tissue. The user, while holding the pointed end, reverses direction along the insertion pathway with the instrument. This releases the length of suture within the instrument and enables the retainers to grasp the surrounding tissue. The instrument clears the wound area and the retainers holding the surrounding tissue keep the wound closed. Such a device is disclosed in U.S. Pat. No. 5,342,376.
Other self-retaining suture technologies are known to the applicants. Table 1 summarizes applicable self-retaining suture technology. Table 1 is attached and, along with its foreign counterparts and any continuations and/or divisionals, is incorporated herein by reference in its entirety.
In spite of the advances made to date relating to self-retaining suture technology, there does not exist a suture length made up of one or more sections containing converging retainer patterns that facilitates the placement of a suture without an attached needle. Such placement would be advantageous in several surgical tissue repair applications wherein the location of the tissue to be repaired constrains the passage and retrieval of an attached suture insertion device or where adjacent tissues could be harmed by the passage of the attached needle such as the passage of a needle past the bladder during the placement of a bladder neck suspension sling. Further, such placement would be useful in certain cases where robotic or other mechanically assisted surgical methods are employed in which simplified suture anchoring methods are desired. Also, such placement would be advantageous in fixing therapeutic devices to delicate tissues such as tumors in which such devices would operate more effectively if they were placed with minimal tissue disruption and if such therapeutic devices were immobilized during the period of therapeutic treatment. Also, such placement reduces the number of attached needles that must be retrieved from the surgical tissue. Thus reducing the established risk of inadvertently leaving needles in the patient after surgery is completed. Further, the manipulation of needles during this process of thread passage and needle retrieval is a well known risk for “needle stick” to the operator that can lead to the transmission of blood borne pathogens such as HIV and hepatitis.
At present, there does not exist any system or method where a length of suture is inserted with a detachable suture insertion device where the suture insertion device may be easily retracted along the needle's insertion pathway. Presently, after tissue or the like is anchored, the surgeon in some cases must continue to move the suture insertion device further through tissue to retrieve the needle. This may result in further damage to the tissue, as discussed above. When the surgeon moves the suture insertion device further through tissue to enable the suture insertion device to exit the body, this also results in the formation of a suture insertion-device-exiting-pathway which creates an opportunity for the suture to migrate from its initial placement position Such migration can lead to movement of the anchored tissue or disconnection of joined tissues relative to each other. Such movement could lead to complete or partial failure of the procedure. Also, the suture itself may migrate into positions that are harmful to adjacent tissue and organs.
A further disadvantage of the present state of the art is that the area tissue surrounding the suture placement may become damaged during the procedure because of the surgeon's need to retrieve the attached needle. Presently, a surgeon must not only insert a suture and any attachment to the desired location, but to retrieve the needle, the surgeon must move the needle through a particular area of tissue to enable the needle to exit. Alternatively, the surgeon may choose to try to reverse the attached needle's pathway at the point of suture placement. In either case, there can be significant disruption to the tissue in the surrounding area. This can become a critical issue where the surgeon is working in the area of a cancerous tumor. If the tumor becomes damaged or as a result of the disruption to tissue, the procedure is ineffective, the cancer may spread or the procedure to treat the cancer may fail. Thus, there is no system or method of placing a suture at a desired location that leaves the surrounding tissue unharmed and undamaged.
Another disadvantage of the present state of art relates to surgical procedures that require a significantly deep incision relative to the size of the incision at the skin level. In particular, endoscopic procedures and surgeries often require minimum incisions at the skin level and yet may be quite deep. As a result, it is often difficult for the surgeon to work in such a cramped environment. Closing this access port is challenging to do with conventional attached needles, especially at the deepest portion s of the narrow opening where there is little room to manipulate a needle driver and forceps to grasp and retrieve an attached needle.
One version of a converging self-retaining suture pattern is in a suture length made up of a continuous loop having converging retainers along at least a portion of the length, wherein the loop is inserted into a section of tissue to support a body part of a mammal. Further, there is no method or device at present that enables a user to accurately and effectively insert a looped length of self-retaining suture into the body of a mammal where the insertion end of the suture length remains within the body of a mammal without the need for holding, joining or pulling on the insertion end of the suture. Such a method or a device would enable a surgeon or other medical personnel to engage in procedures that would deliver more effective treatment to patients while minimizing damage to the surrounding tissue. This would provide greater success rates of certain procedures, decrease recovery time, minimize complications and thus decrease the overall cost to perform such procedures.
Accordingly, it is desired to provide a continuous loop of suture having converging retainers on at least a portion of its length where the loop is inserted into the body of a mammal to support a body part.
It is further desired to provide a method and device for inserting a length of suture having converging retainers along at least a portion thereon, where the inserted end remains within the body of the mammal and does not need to be pulled or manually held or joined to another length thereof.
It is yet further desired to provide a method of support a body part of a mammal by inserting a length of suture having retainers along at least a portion thereof, where the length of suture remains within the insertion pathway and the insertion end of the suture does not need to be held or joined to another length of suture or pulled clear of insertion area for the method to be effective.
It is still further desired to provide a method and device for supporting a body part of a mammal where the length of suture is inserted into the body of mammal at a point that ensures significant effectiveness in the continued support of the body part.
It is yet further desired to provide a method and device for supporting a body part of a mammal where the procedure is minimally invasive, minimizes damage to the body during the procedure recovery time and reduces the overall cost of performing the procedure.
It is yet further desired to provide a method and device for placing sutures in tissue where the procedure is minimally invasive, minimizes damage to the body during the repair procedure, minimizes recovery time and reduces the overall costs of performing the procedure.
It is still further desired to provide a method and device for placing sutures in tissue where the suture is easily detached from the suture insertion device and the suture insertion device is able to be retracted from the tissue by reversing its travel along the insertion pathway.
It is yet further desired to provide a method and device for anchoring a length of suture in a particular location in tissue in such a manner that minimizes the possibility for suture migration and for damage to surrounding tissue.
It is further desired to provide a method and device for anchoring a suture and attachment such as a marker, tack, tag, chemotherapeutic drug delivery agent, seroma evacuation tube or the like into the tissue with great accuracy and with minimal disruption to surrounding tissue.
It is also desired to provide a method and system for ensuring that all needles used in a surgical procedure are retrieved.